UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018248 |
|---|---|
| Receipt number | R000021119 |
| Scientific Title | Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia |
| Date of disclosure of the study information | 2015/07/09 |
| Last modified on | 2022/03/07 08:29:08 |
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Basic information
Public title
Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Acronym
Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Scientific Title
Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Scientific Title:Acronym
Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Region
| Japan |
Condition
Condition
advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty
| Pneumology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and the efficacy of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
OS: overall survival
PFS: progression free survival
TTF: Time to treatment failure
toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carboplatin AUC = 5 , day1
Paclitaxel 70mg/m2, day1,8,15
4-6 cycle
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Squamous cell lung cancer
2) Age over twenty
3) Idiopathic interstitial pneumonia
4) Measurable lesion
5) ECOG performance status 0 or 1
6) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL
7) PaO2>=60.0 torr or SpO2>=92.0 %( room air)
8) No symptoms from brain metastasis
9) Life expectancy > 3 months
10) Written informed consent
Key exclusion criteria
1) Secondly interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) Need to home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications
9) Symptomatic brain metastasis.
10) Uncontrollable effusion.
11) Active combined malignancy
12) Any ineligible case judged by physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Institute of Biomedical Research and Innovation Hospital
Division name
Division of Integrated Oncology
Zip code
Address
2-2, Minatojima Minamimachi Chuo-ku, Kobe 650-0047, Japan
TEL
078-304-5200
katakami@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Osaka Preferctural Medical Center for Respiratory and Allegic Diseases
Division name
Thoracic Oncology
Zip code
Address
3-7-1 Habikino Habikino-shi Osaka 583-8588 Japan
TEL
072-957-2121
Homepage URL
suzukih@opho.jp
Sponsor or person
Institute
IP lung cancer study group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 08 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021119
